Post-Approval Requirements for Drugs: An Introduction to Safety Reporting and Post-Approval Changes

  • Understand regulatory requirements for post-approval safety reporting
  • Explain FDA’s drug safety activities
  • Describe the regulatory framework for post approval changes and supplemental New Drug Applications (NDAs) and Abbreviated NDAs (ANDAs)
  • Understand at a high-level:
    • Grounds for Withdrawal of Approval
    • Medicare, Medicaid and Reimbursement Issues
    • Drug Supply Chain Security Act (DSCSA) Product Tracing Requirements

Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International

This session was recorded as part of FDLI’s Introduction to Drug Law and Regulation Course in November 2023. 

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